This Is MS Multiple Sclerosis Community: Knowledge & Support

The reviewers believe there are no studies matching the criteria of methodological quality necessary for inclusion in their review....but they do not say this is bunk....they encourage researchers to design "robust" trials. Thanks to Marie Rhodes and Ted Robek for gathering resources for review.

http://onlinelibrary.wiley.com/doi/10.1 ... 2/abstract

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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

The doctors who have compiled this review have requested that those interested in CCSVI studies forward this paper to universities and researchers. As they posted on our Facebook page today:



thanks,
cheer

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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
dual stents placed 5/09
CCSVI in MS

with all due respect ..... do we need the Cochrane Review people to tell us that CCSVI needs a Trial ? We know that .

Tell us .... how to make it HAPPEN.


MrSuccess

Posted that in a different thread but it fits here better.
I think it's exciting that the Cochrane review is looking at CCSVI research. They are known as neutral and we could use neutral impartiality.
Not good enough evidence for or against CCSVI.

We make the trial happen by getting more evidence in through the lower level routes (registry, observational studies, autopsies) and then the funding needs to be there and there needs to be academic interest in researching CCSVI. The IRs need to be our champions in driving this, as they have been already.

I do not like trials headed by neurologists that have the procedure done by IRs with no experience. I like trials headed by IRs with experience. Vascular research of CCSVI syndrome as a vascular disease. But if IRs have experience, they are dismissed as being partial or biased. Remember Dr. Sclafani's planned registry study back in 2010? That would have added to the knowledge base. And Dr. Dake's planned trial? I would love to hear an announcement of it getting underway, he is an academic researcher and well-respected.

I am definitely of the opinion that we need this Cochrane Review and that it’s quite important and very valuable in our efforts to try to move research and clinical trials forward.

Given the influence of the NMSS, my read of the “tea leaves” is that the NMSS is definitely opposed to CCSVI (no surprise there), but also to any clinical trials for CCSVI. What entities, individuals or organizations are willing to support a clinical trial now? Who would be interested if/when the NMSS opposes them?

I periodically check out the NMSS web page on CCSVI (Edit 12/14/12--I removed link to this web page as the NMSS has removed and changed links I originally referenced in this post late 12/13/12 WOW).

(1) The NMSS had a link to this author's commentary at the very bottom of their CCSVI page. IDEAL for CCSVI Research. You can see that the full text is available and the author is (and has been) adamantly opposed to CCSVI and CCSVI clinical trials (as you’ll see if you read the full article). Unfortunately, I never saw the NMSS actually link to any info about the proposed IDEAL model for CCSVI research, here.

(2) Previously the NMSS linked the title of the latest article in Pub Med about CCSVI on their page. While the link to pub med still exists, the title of the latest article on CCSVI does not. The NMSS has stopped listing the latest article title. The latest title, if they continued their “tradition”, would be Disability caused by multiple sclerosis is associated with the number of extra-cranial venous stenosis: possible improvement by venous angioplasty. Results of a prospective study.

Now, why exactly would the NMSS feature a researcher who is adamantly opposed to CCSVI and CCSVI clinical trials without a link to information about what the IDEAL model for CCSVI research actually proposed? And, why not continue their “tradition” of a link and title to the most recent Pub Med article on CCSVI? (Edit 12/14/12--the NMSS changed their CCSVI web page and this is now present). WOW......

As I said, I’m reading “tea leaves” here because to the best of my knowledge the NMSS hasn’t taken a position on clinical trials yet, but featuring an article opposed to clinical trials raised my eyebrows.

Hats off to and thank you Cochrane reviewers. I hope to be able to read the full article and hope many researchers and others do as well. May be a good read for the NMSS.

Take care all

Sharon

(Cece--just saw your post)

PubMED nicely gives you links to other papers. I saw one, and blindly clicked it:



Some of their data came from Canadian MS patients!

The guy who calls for the IDEAL model seems to think there is "no evidence." Cochrane claimed this same thing.

I disagree.

There may not be gold-plated unassailable evidence of the kind needed for an unknown drug like acetaminophen (Tylenol) to replace a popular drug like acetylsalicylic acid (Aspirin), but let's call a spade a spade. There is lots of evidence. From large studies and small, forward and backward-looking. If someone wants to heap scorn on it, they have free speech. You don't have to listen to the people who say the world will end either.

(Many of you may not remember, but I remember a time when Aspirin was the only popular headache remedy most people had ever heard of.)

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

It is a pity that the Cochrane reviewers do not appear to have taken account of the UK's NICE Guideline when writing their paper. NICE Guideline IPG420 may be viewed at: http://www.nice.org.uk/nicemedia/live/1 ... /58610.pdf
As someone who assisted NICE by submitting documents, I was pleased that NICE did not apply the term 'randomised' to its recomodations for clinical trials. The Cochrane reviewers fell into the trap of wanting randomised trials. This fails to appreciate that pwMS (trial subjects) are awake and can feel inflation of the balloon, which makes random assignment to treatment or non treatment groups extremely difficult under ethics applied in the UK.
If anyone is aware of a process for published official replies to a Cochrane rewiew please let me know. As it would help if the Cochrane group reviewed NICE's guideline. The NICE guideline is correct when it called for robust trials. Robust trials for this procedure are going to be difficult, without asking the the impossible? requirement of randomisation.
MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

I had the procedure in Albany. While I may have even been marginally conscious, I don't remember even much about the trip back to the hotel room. I remember mainly feeling better the next day. I was reportedly better in my speech, cognition, energy, and ability. I went immediately from wheelchair to walker,as I was no longer too dizzy to stand. I had bruises all over my body, which I don't have now. I have been able to stand up from sitting in lower chairs ever since.

Anyway, I think under sedation (not general anaesthesia) painkillers are not even necessary, though certainly could be used. Unless the patient is very alert and intending to be as aware as possible, the ballooning can be ignored. If, as in my case, they have no intention of feeling anything, there is no need to. I could have been more conscious, and maybe being more responsive to requests to breathe deeply, etcetera, would have been helpful, but I do not think there is any need for a person to feel, or remember feeling, ballooning.

Weighing against that, some people avoid medicines, some people react less to them, and some people require different levels of treatment. The upshot is, everyone is different, which renders any attempt to generalize from small numbers difficult. When invasive procedures are being tested, only large studies will benefit from randomization.

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

I trust Dr. Sclafani on this one, and he says that he wants people conscious so they can follow those instructions which can help optimize the examination and procedure.

One of my concerns with the randomized trials is if IRs involved can perform an optimized procedure. Sedating takes away from that optimization. Never having done the procedure before takes away from the optimization. Not using IVUS. Etc etc. We have seen back in 2010 that IRs who don't know what they're doing (which no one did, because it was the beginning) can worsen the outflow when they're attempting to improve the outflow.

What do you think qualifies as large numbers? Is the $6 million Canadian study looking at 50 patients in the treated category and 50 in the sham? I might have those numbers wrong.

I am discouraged. I want good care for myself and everyone with MS. If treatment of CCSVI outflow obstructions is a fundamental part of that good care, I want that to be established definitively and soon. It is taking a long time and there is such hostility.

They can control many things with the right substances, including whether or not, and when, you feel ballooning. They used 10 things on me for laporoscopic gall bladder removal. Conscious cooperation is also controllable. For my stents I had only a nurse administering intravenous valium. I could not tell you if they ballooned me, but I know they were in my leg without permission. I only had 2 tablets of it with Dr. Siskin, but I slept like a baby.

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"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'_MS' is over - if you want it
Patients sans/without patience

Hello Cece and 1eye,
You are both highlighting issues with trials. Starting with Cece's thought that we need agreed tools (including IVUS). Until this is agreed there is no point in starting trials - why treat some stenoses but leave others ? Most doctors investigate fewer veins than DrS so for me that invalidates their data - they may be sub-treating. Yes I realise that means the Hubbard Registry data cannot be combined with DrS's and maybe others data.
1eye shared his experience of venoplasty, mine were different. In a trial sedation of patients must be standardised for everyone. No un-necessary drugs (sedatives) may be given in a UK trial for ethical reasons Designing a trial procedure is a big problem.
For me, the first trial needed is a multi-centre one using agreed tools and an agreed list of veins. This would tell us the incidence of CCSVI syndrome in the veins of pwMS. Do you agree???
Best wishes for 2013,
MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

It would be nice if there was consensus among the investigators regarding the tools to be used and the veins to be checked, not to mention all the technical details of treatment. I would prefer to see treatment trials, but only if treatment is optimally done. A trial to see what the incidence is of CCSVI syndome in veins of pwMS is shooting lower, it's back to looking at if there is an association between CCSVI and MS, but then again that association seems to remain in doubt. Great post, MarkW, although did I read that correctly that you think the Hubbard Registry data is invalidated?

To clarify:
"Most doctors investigate fewer veins than DrS so for me that invalidates their data - they may be sub-treating." I was sub treated in June 2010 as there was no better information. If Interventionists are sub-treating in 2013 that is a problem for people paying for de-stenosis.
"I realise that means the Hubbard Registry data cannot be combined with DrS's and maybe others data". To combine data (as Cochrane does) requires a similar method to be used. I do not know if all doctors on the Hubbard Registry are using the same diagnostic tools or treating the same named veins, so I do not know if the data is scientifically combinable. Do you know any details?

I agree with you that pwMS seeking 'de-stenosis by venoplasty' need to know that the best diagnostic tools are being used on named veins (long list) in which stenoses have been found. Then we need to know that all the stenoses found are treated using the best methodology. I feel we pwMS are a long way away from this at most clinics. I hope that the leading experts in CCSVI start givng us answers in Poland.
Kind regards,
MarkW

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

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Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html

No details but I can recognize that that's a good question. I'd have to look again at the names but from what I recall, they are all doing angioplasty of the jugular and azygous but other methods such as the use of IVUS or other veins that are investigated will vary.

One of the strengths of multicenter trials or in this case registries would be that the different IRs have different skill levels and combining the data allows the differences to be smoothed out. Would that have the same effect for differences between methods?

I am convinced that they are not testing the optimal methods: 1) because the IRs are in disagreement about optimal methods and 2) because IVUS is not used by most IRs.

Here we go, this was updated in Sept 2012

https://maps.google.com/maps/ms?ie=UTF8 ... 75b82cdfc8

Yeah the methods used by Dr. McGuckin, Dr. Ferral, Dr. Ponec, DIR, Dr. Solis and Dr. Sperling greatly differ.
Dr. Ferral may be the best of them because he uses IVUS. Dr. McGuckin has considerable experience and investigates the full list of veins. Dr. Ponec has considerable experience as well, I think he may be more conservative in his approach? DIR has far less experience. I am not familiar enough with Dr. Solis or Dr. Sperling so they are spared my offering an opinion on their techniques.